Assess Measurements of Wireless Cardiac Output Device

Completed

• Conditions: Congestive Heart Failure

• Registration Number: NCT02252757
• Lead Sponsor: Aventyn, Inc.

Brief Summary

Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system

Detailed Description

Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, thoracic fluid, heart rate, heart rate variability, respiration rate, stroke volume, cardiac output, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation. Programs for chronic heart failure that include remote monitoring have been shown to have a positive effect on clinical outcomes in community dwelling patients with chronic heart failure.

In preparation for a study evaluating the effectiveness of mobile monitoring, the value of Stroke Volume and Cardiac Output need to be validated against FDA approved devices that are available in a hospital or clinic setting. This study covers the validation of the measurements taken with the proposed home monitoring device, Perminova's CoVaTM Sensor (Sensor) against clinic devices such as bio-impedance devices, echocardiogram, Doppler and/or MRI

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-20
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Subjects of either gender above the age of 18 years
• The subject is able and willing to provide written informed consent prior to enrollment in the study
• One or more of the following diagnosis
• New York Heart Association (NYHA) classification class of I-IV or Stages A-D
• Symptoms of dyspnea
• Chronic renal failure on renal replacement therapy

Exclusion Criteria

• Patients who may not come for follow up or likely to drop out of the study
• Any illness which may preclude regular follow up
• Patient is unable or not willing to wear electrode patches as required
• Patient has skin sensitivity to adhesive or hydrogel materials used in electrode patches
• Patient is considered by the PI to be medically unsuitable for study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring Cardiac Output for wireless transmission as per discharge guideline	2 Weeks

Trial Locations

Locations (1)

Scottsdale Cardiovascular Center; 🇺🇸 Scottsdale, Arizona, United States